One German Term, Two English Ones: A Glossary That Collapses a Regulatory Distinction
DE into EN: a 40-page instructions-for-use document for a Class IIb infusion pump, feeding both EU MDR technical documentation and a US 510(k) at once. The client glossary, marked “approved,” maps Zweckbestimmung and bestimmungsgemäßer Gebrauch both to “intended purpose,” and the glossary owner is on leave until after Friday's deadline. Source: «Das Gerät ist ausschließlich für den bestimmungsgemäßen Gebrauch durch autorisiertes Fachpersonal bestimmt; die Inbetriebnahme darf nur nach erfolgter Einweisung durch den Hersteller erfolgen.» A warning reads: «Die Anwendung darf ohne vorherige Prüfung der Schlauchkassette nicht erfolgen.» The translation memory contains 2016 segments using “proper use” and “commissioning.”
1. Do you follow the approved glossary? Argue the decision and give your renderings.
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I deviate, and I document it.
Zweckbestimmung is the manufacturer's stated purpose of the device - the MDR term “intended purpose.” Bestimmungsgemäßer Gebrauch is use in accordance with that purpose. Collapsing both produces sentences like “The device is intended exclusively for intended purpose,” which is ungrammatical and, worse, erases the distinction a notified body reads for. A single target term for two source concepts is a defect in the glossary, not a style preference.
Renderings: Zweckbestimmung → “intended purpose”; bestimmungsgemäßer Gebrauch → “use for its intended purpose” (or “intended use” where the sentence needs a noun phrase and the 510(k) audience expects it).
Process: I write a deviation note with the rationale and both terms, apply it consistently across all 40 pages, tell the project manager before delivery, and flag it for the glossary owner's return. Consistent deviation with a stated reason is defensible; inconsistency is not. I do not simply follow the glossary because it says “approved,” and I do not ignore it in silence either.
2. Render the two sentences, paying attention to Inbetriebnahme, erfoldter Einweisung, and the scope of the negation in the warning.
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First sentence. Inbetriebnahme is putting the device into service for the first time - “commissioning,” “start-up,” or “first use” - not “operation.” Erfolgter Einweisung means training that has already taken place, so “only after the manufacturer has trained the operator” or “only after training by the manufacturer” (the participle carries completion).
“The device is intended exclusively for use for its intended purpose by authorized specialist personnel; it may be put into service only after training by the manufacturer.” (“Authorized specialist personnel” can often become “authorized trained personnel” in US labeling; that is a separate, logged choice.)
Warning. The German is a nominal negative, and carried over literally it becomes “Use must not take place without prior checking.” Render it as a direct prohibition with the prerequisite intact: “Do not use the device without first checking the tubing cassette.” That preserves both the prohibition and the ordering of the two actions. Rewriting it as “Check the tubing cassette before use” is friendlier but drops the prohibition, and in a warning section the prohibition is the operative content.
3. What do you do with the 2016 memory segments using “proper use” and “commissioning”?
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I treat them as evidence, not as authority.
“Proper use” is a vague phrase that in a safety context can mean correct technique, correct indication, or use consistent with labeling. It is also unsearchable for a reviewer checking a defined MDR concept. “Commissioning” is ordinary engineering English in the UK and EU, but a US 510(k) reviewer may read it as facilities commissioning rather than device start-up. Both choices were reasonable in 2016 and neither is wrong in the abstract; the problem is that they predate the current regulatory alignment and would now sit alongside my “intended purpose” terminology.
So I lock one term per concept across the whole document and do not accept matches just because they are 100 percent fuzzy matches. I also check whether the 2016 rendering sits inside labeling that was formally approved; if it does, the change is a change-control matter for the client's regulatory team, and I say so in the delivery note rather than letting the terminology shift quietly.